Compliance: Getting Those Ducks in a Row - Pharmaceutical Executive


Compliance: Getting Those Ducks in a Row

Pharmaceutical Executive

Silencing Off-Label Marketing: Profit Versus Information

Many times, physicians prescribe drugs for an indication other than the one on the label that has the FDA seal of approval. And patients come to rely on those drugs. The difficulty here lies in the fact that no matter how many physicians and patients swear by a drug's ability to improve health in some way, if it's not on the label, pharma marketing must stay mum. In the past, heavy fines have been imposed on pharma for off-label marketing, but compared to the profit to be made from off-label use, those fines can be just a drop in the bucket.

Some believe, however, that current FDA compliance regulations around marketing have all but eliminated the problem of off-label marketing—perhaps with some collateral damage in the form of the loss of other valuable information. Rather than offering up too much information in its marketing campaigns and being willing to accept the risk of subsequent fines, says Steve Smith, chief marketing officer for M3, pharma is often so afraid of saying the wrong thing that it may play it safe by preferring to say almost nothing at all.

"Every word that a pharmaceutical company prints or puts on a website or into a commercial is looked at by a brand manager, a brand team, a compliance team, a lawyer. And it is crafted down to the smallest word to make sure that nothing is said that will appear to be out of focus to the FDA," says Smith. "The regulatory scrutiny is amazing."

The issue, he says, is a lack of trust on both sides. "My impression is that pharma often distrusts FDA to look reasonably and objectively at its promotional programs, and FDA distrusts pharma to promote its drugs truthfully." And so pharma must navigate carefully to avoid sinking its own ship.

Because of the shakiness of this relationship, Smith maintains that any off-label marketing issues he's seen in pharma lately have been—rather than Big Pharma arrogantly going after profit despite potential penalties—unintentional slip-ups that sometimes result in FDA warning letters.

Other gray areas in off-label arise in dialogues between overzealous sales reps and physicians, Smith says. "It's odd to have a dialogue between two professionals where the reps have to say, 'Oops, I can't talk to you about that,' but that's actually what's supposed to happen," he says. "The sales people cannot talk about anything that's off-label, no matter how valuable that information is. So the companies aren't misrepresenting their products by talking about off-label indications, but then who is talking about those? The government is not funding education to tell the doctors about it, so who is? At the end of the day, you do have to ask the question: 'Where's the patient advocacy in this?'"

Admittedly, these regulations are in place for a reason, and pharma has certainly been guilty of pushing the envelope too far and abusing its marketing freedoms in the past. "Pharma gets beat on the head a lot, and we see bad news about them a lot. And they deserve much of it, because they're operating like any other business. They're operating because they have investors, and it's sad to say, but yes, they're operating for the bottom line. And they happen to do that in a place where people's health is more obviously on the line than in other industries." The danger, says Smith, lies in curbing vital information along with curbing promotional language—are we throwing the baby out with the bathwater?

"In the mid '90s, a top 10 pharma ran a nationwide education program in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) that reached hundreds of thousands of physicians and allied healthcare practitioners, improving their knowledge and their treatment of asthma, when it had been clearly shown that doctors were not up on the times with how to treat asthma. And yes, they did it for promotional purposes, but it was a massively successful program from the educational side," says Smith. "So in the past, there have been both benefits and abuses. And with the regulations now, we don't get the benefits. We get a lot less benefits and a lot less abuses. We've trimmed off both ends."


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